DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application claims priority from provisional application 63/304,022.
Status of Claims
Claims 1-20 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 06/24/2024 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 3, 8, 9, and 16-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2, 3, 8, 9, and 16-20 are rendered indefinite by the requirement for components to be “generally parallel” / “generally perpendicular”. the term parallel is not a term of degree open for broad interpretation. Parallel is a simple term which two objects either meet or do not. If a line is “generally parallel” to a base line, then it by definition is not parallel to the base line because they will eventually intersect. Therefore, the tabs of the applicant's invention cannot be “generally parallel” to the axis, it would either be parallel or not parallel. The same goes for the term perpendicular. Objects must extend at 90 degrees from each other to be perpendicular, so they cannot be generally perpendicular.
Claims 2, 8, and 16 recite “generally perpendicular” in line 3
Claims 3, 9, 17, and 20 recite “generally parallel” in line 2
Claim 18 recite “generally perpendicular” in line 9
Claim 18 is rendered indefinite because it repeats the same clause two times. Both line 9 and line 10, recite “the base having a first length”. It is unclear if the applicant intended to define additional lengths or is referring to the same length. The applicant is advised to delete the recitation from claim 10.
Claims 16, 17, 19, and 20 are rendered indefinite by the requirement for the base to extend into the groove and the leg to be parallel to the axis after positioning of the tabs into the grooves. It is unclear how these two aspects can happen after the step of positioning the tab within the groove. First, only the base is positioned within the groove, so the initial placement of the tab into the groove will inherently include the step of placing the base into the groove. Therefore, it cannot occur after the initial step. Second, the legs are generally parallel to the axis in their initial configuration which is long before the insertion of the tab in the groove. Even with a slight bend to allow for the insertion they appear to still be generally parallel to the axis. Therefore, it cannot occur after because it clearly takes place before. The applicant is advised to delete the “after the step of…” clauses from these claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dwork US 2011/0251675 A1.
1. Dwork discloses the same invention being a system comprising:
a valve prosthesis 20 including a frame 22 and a prosthetic valve 24 disposed within the frame (Figures 1AB), the frame being self-expanding (nitinol frame is self-expanding [0032]) and including a plurality of attachment tabs 40 extending from a first end of the frame (Figures 1AB); and
a delivery system (Figure 3) for percutaneously delivering the valve prosthesis, the delivery system including a shaft 54 , a piston 56 disposed over the shaft (Figure 7A), and a capsule, the capsule 52 [0036] being movable relative to the piston ([0036] discloses the withdraw of the sheath over the prosthesis and piston), wherein the piston includes an annular groove (130 142) on an outer surface thereof (Figures 4AB),
wherein in a delivery configuration of the delivery system the plurality of attachment tabs are disposed within the annular groove of the piston (Figures 7AB) and the capsule covers and constrains the valve prosthesis in a radially collapsed configuration (Figure 7A), with the capsule extending over the annular groove of the piston and the attachment tabs received therein (Figure 7A).
15. Dwork discloses the same invention being a method of coupling a valve prosthesis to a delivery system for delivery thereof (Figure 7AB), the method comprising:
positioning a plurality of attachment tabs 40 of the valve prosthesis 20 into an annular groove of a piston 56 of the delivery system (Figure 3), the valve prosthesis including a frame 22 and a prosthetic valve 24 disposed within the frame (Figures 1AB), the frame being self-expanding (nitinol frame is self-expanding [0032]) and including the plurality of attachment tabs extending from a first end of the frame (Figures 1AB); and
positioning at least a portion of the valve prosthesis into a capsule of the delivery system (Figures 7AB) such that the capsule covers and constrains the valve prosthesis in a radially collapsed configuration (Figures 7AB), with the capsule extending over the annular groove of the piston and the attachment tabs received therein (Figures 7AB).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-6, 8-12, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dwork in view of Wang et al (Wang) US2007/0293930 A1.
Dwork discloses the invention substantially as claimed being described above. However, Dwork does not disclose the tabs are L-shaped.
Wang teaches the use of a variety of interchangeable tab shapes (Figures 8A-N) including T shapes similar to Dwork (Figures 8CD) and L shapes (Figure 8KL) because they are all structural equivalents and provide the same benefits.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the T-shaped tab of Dwork with the L-shaped tab of Wang in order to provide a simplified shape with a single orientation.
2. Dwork as modified discloses each attachment tab of the plurality of attachment tabs has an L-shaped configuration (Wang Figure 8K) and includes a leg (near 12x Figure 8K), a base (near 101 Figure 8K), and a bend extending between the leg and the base (Figure 8K), the base extending generally perpendicular to a longitudinal axis of the delivery system (Figure 1A of Dwork shows how the base would extend perpendicularly) and being configured to extend into the annular groove of the piston (Figures 7AB).
3. and 9. Dwork as modified discloses the leg of each attachment tab of the plurality of attachment tabs extends generally parallel to the longitudinal axis of the delivery system (Figure 1A of Dwork shows how the leg would extend parallel to the axis).
4. and 10. Dwork as modified discloses the leg of each attachment tab of the plurality of attachment tabs extends at an acute angle relative to the longitudinal axis of the delivery system (Figure 8D of Dwork shows how the leg can be bent to flex with respect to the longitudinal axis, this allows for a variety of angles including an acute angle).
5. and 11. Dwork as modified discloses the bend of each attachment tab of the plurality of attachment tabs has a curved profile (See Wang Figure 8KL).
6. and 12. Dwork as modified discloses the bend of each attachment tab of the plurality of attachment tabs forms an angle between the leg and the base, the angle being between 80 and 100 degrees (See Wang’s 90-degree bend in Figure 8KL).
8. Dwork as modified discloses a system comprising:
a valve prosthesis 20 including a frame 22 and a prosthetic valve 24 disposed within the frame (Figures 1AB), the frame being self-expanding [0032] and including a plurality of attachment tabs 40 extending from a first end of the frame (Figure 1A); each attachment tab of the plurality of attachment tabs having an L-shaped configuration (See Wang Figures 8KL) and including a leg (Wang 12x), a base (Wang 101), and a bend extending between the leg and the base (See Wang Figures 8KL), the base extending generally perpendicular to a longitudinal axis of the delivery system (Figure 1A of Dwork shows how it extends perpendicularly but with a T-shape) and the base having a first length (as modified it would be just the left half of the T-shape in Figure 1A of Dwork); and
a delivery system (Figure 3) for percutaneously delivering the valve prosthesis, the delivery system including a shaft 54, a piston 56 disposed over the shaft (Figure 7A), and a capsule 52, the capsule being movable relative to the piston [0036], wherein the piston includes a circumferentially extending groove on an outer surface 142 thereof, the circumferentially extending groove having a length that is at least 300% greater than the first length of the base of an attachment tab of the plurality of attachment tabs (Figures 4AB),
wherein in a delivery configuration of the delivery system an attachment tab of the plurality of attachment tabs is disposed within a circumferentially extending groove (Figures 7AB) and the capsule covers and constrains the valve prosthesis in a radially collapsed configuration (Figures 7AB), with the capsule extending over the circumferentially extending groove and the attachment tabs received therein (Figures 7AB).
However, Dwork does not disclose a plurality of circumferentially extending grooves.
Wang teaches the use of a plurality of circumferential grooves instead of having a single circumferential groove (top of Figure 9) including lengths that are greater than 300% of a length of the tab (the tabs have a variety of lengths due to their curves/bends) for the purpose of allowing for easier insertion of the tabs.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the single groove of Dwork with a plurality of separate oversized grooves as taught by Wang in order to provide easier insertion of the tabs.
16. and 19. Dwork as modified discloses each attachment tab of the plurality of attachment tabs has an L-shaped configuration (Wang Figure 8K) and includes a leg (near 12x Figure 8K), a base (near 101 Figure 8K), and a bend extending between the leg and the base (Figure 8K), the base extending generally perpendicular to a longitudinal axis of the delivery system (Figure 1A of Dwork shows how the base would extend perpendicularly) and being configured to extend into the annular groove of the piston (Figures 7AB), wherein the base of each attachment tab of the plurality of attachment tabs extends into the annular groove of the piston after the step of positioning the plurality of attachment tabs of the valve prosthesis into the annular groove of the piston of the delivery system (see 112 rejection above, both the prior art and the applicant’s invention function in the same manner and read upon this limitation in the same manner).
17. and 20. Dwork as modified discloses the leg of each attachment tab of the plurality of attachment tabs extends generally parallel to the longitudinal axis of the delivery system (Figure 1A of Dwork shows how the leg would extend parallel to the axis) after the step of positioning the plurality of attachment tabs of the valve prosthesis into the annular groove of the piston of the delivery system (see 112 rejection above, both the prior art and the applicant’s invention function in the same manner and read upon this limitation in the same manner) each attachment tab of the plurality of attachment tabs having an L-shaped configuration and including a leg, a base, and a bend extending between the leg and the base, the base having a first length and extending generally perpendicular to a longitudinal axis of the delivery system, the base having a first length and each circumferentially- extending groove having a length that is at least 300% greater than the first length; and
positioning at least a portion of the valve prosthesis into a capsule of the delivery system such that the capsule covers and constrains the valve prosthesis in a radially collapsed configuration, with the capsule extending over the plurality of circumferentially- extending grooves of the piston and the attachment tabs received therein.
18. Dwork discloses the same invention being a method of coupling a valve prosthesis to a delivery system for delivery thereof (Figure 7AB), the method comprising:
positioning a plurality of attachment tabs 40 of the valve prosthesis 20 into a plurality of annular grooves of a piston 56 of the delivery system (See modification in view of Wang referencing claim 8 above), the valve prosthesis including a frame 22 and a prosthetic valve 24 disposed within the frame (Figures 1AB), the frame being self-expanding (nitinol frame is self-expanding [0032]) and including the plurality of attachment tabs extending from a first end of the frame (Figures 1AB);
each attachment tab of the plurality of attachment tabs having an L-shaped configuration (Wang Figure 8K) and including a leg (near 12x Figure 8K), a base (near 101 Figure 8K), and a bend extending between the leg and the base (Figure 8K), the base having a first length and extending generally perpendicular to a longitudinal axis of the delivery system, the base having a first length and each circumferentially- extending groove having a length that is at least 300% greater than the first length (See modification in view of Wang referencing claim 8 above); and
positioning at least a portion of the valve prosthesis into a capsule of the delivery system (Figures 7AB) such that the capsule covers and constrains the valve prosthesis in a radially collapsed configuration (Figures 7AB), with the capsule extending over the annular groove of the piston and the attachment tabs received therein (Figures 7AB).
Claim(s) 7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drwork and Wang (Combination 1) as applied to claims above, and further in view of Pung et al (Pung) US 11,000,394 B2.
Combination 1 discloses the invention substantially as claimed being described above. However, Combination 1 does not disclose the spherical ball at the free end of the tab.
Pung teaches the use of spherical balls at the ends of anchoring tabs in the same field of endeavor for the purpose of providing a greater thickness that self-centers within a rounded portion of the groove.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the spherical ball as taught by Pung with free end of the tab in order to self-center end better resist movement within the groove.
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art of record fails to disclose a plurality of L shaped tabs in a plurality of grooves having greater than 300% the length of the base of the tabs, wherein there are equal number of tabs and grooves.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/ Primary Examiner, Art Unit 3774
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